Le Lézard
Classified in: Health
Subject: FDA

First FDA approved Potassium Phosphates Injection from CMP Pharma Has Been Approved.


FARMVILLE N.C., Feb. 27, 2020 /PRNewswire/ -- Specialty pharmaceutical company CMP Pharma, Inc. announced today that its Potassium Phosphates Injection, the first ever FDA Approved Potassium Phosphates Injection, was approved on September 19, 2019. This will provide Health Care Providers, for the first time, an FDA approved potassium phosphates injection. The availability of this product will help alleviate supply concerns from previous market shortages of this critical phosphate repletion treatment. CMP Pharma's Potassium Phosphates Injection will be available from National and Regional wholesalers.

Potassium Phosphates Injection is indicated as a source of phosphorus in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated.  Additionally, it is indicated as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. 

For more information, contact CMP Pharma at 252-753-7111.

About this Product

CMP's Potassium Phosphates Injection provides a stable, reliable, and easy-to-dose therapeutic option to healthcare professionals. Many practitioners and pharmacists are unaware that all current potassium phosphates formulations on the market today are products that have not been approved by the FDA. These unapproved products have not undergone FDA's review process for quality, safety and efficacy and therefore can expose patients, as well as physicians, to unknown risks.

A major concern with the unapproved potassium phosphates formulations is aluminum toxicity. The FDA has established allowable limits for aluminum in injectable products, and current unapproved potassium phosphates injectable products on the market significantly exceed these limits.

CMP's Potassium Phosphates Injection will help address the critical demand for potassium phosphates while providing physicians and their patients with a product that meets FDA standards for quality, safety and efficacy.

Important Safety Information

INDICATIONS AND USAGE
POTASSIUM PHOSPHATES INJECTION is a phosphorus replacement product indicated as a source of phosphorus:

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

DRUG INTERACTIONS 
Use of Other Medications that Increase Potassium: Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations.

DOSAGE AND ADMINISTRATION

ADVERSE REACTIONS
Adverse reactions are hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia.

To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About CMP Pharma, Inc.

CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value pharmaceutical products, including liquids and semi-solids. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients.

SOURCE CMP Pharma


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News published on 27 february 2020 at 09:37 and distributed by: